About this trial
Study objectives:
To determine the optimal timing of coronary angiography (CAG) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) complicated by acute decompensated heart failure (AHF). The primary objective of this trial is to test the hypothesis that immediate CAG ≤2 hours after establishment of NSTEMI diagnosis would result in a significant reduction in primary composite outcome of death from any cause, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF) at 12 months after randomization as compared with delayed CAG after stabilization.
Study hypothesis:
Immediate CAG ≤2 hours after establishment of NSTEMI diagnosis would result in a significant reduction in primary composite outcome of death from any cause, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF) at 12 months after randomization as compared with delayed CAG after stabilization.
Background:
Although current guidelines recommend early CAG within 2 hours for patients with NSTEMI complicated by AHF, many patients with NSTEMI complicated by AHF did not receive early CAG. However, no randomized clinical trials have evaluated the optimal timing of CAG in patients with NSTEMI complicated by AHF. Therefore, the investigators aimed to perform a prospective, investigator-initiated, open-label, muilticenter trial to compare the efficacy and safety between immediate CAG (CAG \<2 hours after establishment of NSTEMI diagnosis) and delayed CAG after stabilization (i.e. improved dyspnea and disappearance of pulmonary congestion) in participants with NSTEMI complicated by AHF.
Study procedure:
Following the establishment of NSTEMI diagnosis, participants fulfilling the eligibility criteria will be randomized at a ratio of 1:1 to immediate CAG ≤2 hours after randomization or delayed CAG after stabilization on another day during hospitalization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥19 years
Non-ST-segment elevation myocardial infarction
New-onset or worsening of dyspnea (New York Heart Association class ≥2)
Pulmonary congestion
Disqualifiers
Cardiogenic shock at initial presentation
ST-segment elevation myocardial infarction
ST-segment elevation ≥0.1 mV in at least 2 contiguous leads, or
New onset left bundle branch block
Trial design
Parallel
Treatments tested in this trial
Immediate coronary angiography
Procedure/SurgeryImmediate coronary angiography ≤2 hours after randomization
Delayed coronary angiography
Procedure/SurgeryDelayed coronary angiography after stabilization
Treatment groups
Trial outcomes
Primary outcomes
A cumulative incidence rate of all-cause death, non-fatal myocardial infarction (MI), or hospitalization for heart failure (HF)
Secondary outcomes
A cumulative incidence rate of all-cause death, non-fatal MI, or hospitalization for HF
All-cause death
Non-fatal MI
Hospitalization for HF
Sponsors and contacts
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